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  • 1. Aims and Scope

    Gut and Liver is an international journal of gastroenterology, focusing on the gastrointestinal tract, liver, biliary tree, pancreas, motility, and neurogastroenterology. Gut atnd Liver delivers up-to-date, authoritative papers on both clinical and research-based topics in gastroenterology. The Journal publishes original articles, case reports, brief communications, letters to the editor and invited review articles in the field of gastroenterology. The Journal is operated by internationally renowned editorial boards and designed to provide a global opportunity to promote academic developments in the field of gastroenterology and hepatology. +MORE

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    Yong Chan Lee Professor of Medicine
    Director, Gastrointestinal Research Laboratory
    Veterans Affairs Medical Center, Univ. California San Francisco
    San Francisco, USA

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    Jong Pil Im Seoul National University College of Medicine, Seoul, Korea
    Robert S. Bresalier University of Texas M. D. Anderson Cancer Center, Houston, USA
    Steven H. Itzkowitz Mount Sinai Medical Center, NY, USA
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    All papers submitted to Gut and Liver are reviewed by the editorial team before being sent out for an external peer review to rule out papers that have low priority, insufficient originality, scientific flaws, or the absence of a message of importance to the readers of the Journal. A decision about these papers will usually be made within two or three weeks.
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Bismuth-Based Quadruple Therapy for Clarithromycin-Resistant Helicobacter pylori Infection: Effectiveness and Cost-Efficiency

Moon Won Lee , Gwang Ha Kim

Department of Internal Medicine, Pusan National University College of Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, Korea

Correspondence to: Gwang Ha Kim
ORCID https://orcid.org/0000-0001-9721-5734
E-mail doc0224@pusan.ac.kr

See “Bismuth-Based Quadruple Therapy versus Metronidazole-Intensified Triple Therapy as a First-Line Treatment for Clarithromycin-Resistant Helicobacter pylori Infection: A Multicenter Randomized Controlled Trial” by Seung In Seo, et al. on page 697, Vol. 16, No. 5, 2022

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Gut Liver 2022;16(6):807-808. https://doi.org/10.5009/gnl220414

Published online November 15, 2022, Published date November 15, 2022

Copyright © Gut and Liver.

Clarithromycin-based triple therapy (CTT) is widely used for empirical first-line eradication of Helicobacter pylori. However, the efficacy of empirical CTT has gradually decreased with the increase in antibiotic resistance. Guidelines in Europe and the U.S. state that CTT is no longer recommended as the first-line therapy in areas with >15% clarithromycin resistance.1,2 A recent study showed that the resistance rate against clarithromycin was 17.8% and eradication rate of empirical CTT was 71.6% in Korea.3 Therefore, finding an optimized, cost-effective, and tailored therapy according to clarithromycin resistance is of paramount importance.

In the latest issue of Gut and Liver, Seo et al.4 compared both the efficacy and cost-effectiveness of tailored therapy as a first-line treatment using sequencing-based clarithromycin resistance testing. Eradication rates of the 14-day bismuth-based quadruple therapy (BQT) were not significantly different from that of 14-day metronidazole-intensified triple therapy (MIT) in an intention-to-treat analysis (80.4% vs 69.7%, p=0.079), but were significantly higher in the per-protocol analysis (95.1% vs 76.4%, p=0.001). Current Korean guidelines recommend 7-day proton pump inhibitor, amoxicillin, metronidazole (PAM) or 10- to 14-day BQT for clarithromycin-resistant H. pylori infection.5 However, 7-day PAM showed a significantly lower eradication rate owing to a high resistance rate against metronidazole. Metronidazole resistance is generally overcome by increasing the dose or treatment duration. In this study, eradication rate of 14-day MIT was not significantly different from that of a previous 7-day PAM study.6 In contrast, intention-to-treat and per-protocol eradication rates with 14-day BQT were 80.4% and 95.1%, respectively, reaching the recommended target rate for first-line treatment. There were no significant differences in non-compliance and prevalence of side effects between the BQT and PAM groups. Thus, 14-day BQT is an effective first-line therapy for clarithromycin-resistant H. pylori infections.

In this study,4 cost-effectiveness analyses of tailored therapy were compared with empirical CTT in first-line and second-line therapies using incremental cost-effectiveness ratio. BQT is more cost-effective than MIT. However, cost-effectiveness analysis showed an increased cost of tailored therapy compared to empirical CTT. The incremental cost-effectiveness ratio was higher in the BQT of second-line rescue therapy than in empirical CTT. This is because the sequencing-based clarithromycin resistance test (USD 57.5) used for tailored therapy is more expensive than the CLO test (USD 9.3) used for empirical therapy. When comparing regimens, cost-effectiveness is determined by efficacy of the regimen and not by its cost. Therefore, acceptance will likely be owing to socioeconomic costs, increasing antibiotic resistance, and disease prevention, whilst minimizing further utilization of healthcare resources, and eradicating H. pylori by saving on treatment costs.

In summary, 14-day BQT showed a higher eradication rate in per-protocol analysis and a comparable incidence of side effects to 14-day MIT as a first-line treatment, according to the sequencing-based clarithromycin resistance test. Moreover, it may be more cost-effective than a 14-day MIT. Tailored therapy may be increasingly used as a first-line treatment for H. pylori, and BQT should be recommended for clarithromycin-resistant H. pylori infection.

G.H.K. is an editorial board member of the journal but was not involved in the peer reviewer selection, evaluation, or decision process of this article. No other potential conflicts of interest relevant to this article were reported.

  1. Chey WD, Leontiadis GI, Howden CW, Moss SF. ACG clinical guideline: treatment of Helicobacter pylori infection. Am J Gastroenterol 2017;112:212-239.
    Pubmed CrossRef
  2. Malfertheiner P, Megraud F, O'Morain CA, et al. Management of Helicobacter pylori infection-the Maastricht V/Florence consensus report. Gut 2017;66:6-30.
    Pubmed CrossRef
  3. Lee JH, Ahn JY, Choi KD, et al. Nationwide antibiotic resistance mapping of Helicobacter pylori in Korea: a prospective multicenter study. Helicobacter 2019;24:e12592.
    Pubmed CrossRef
  4. Seo SI, Lim H, Bang CS, et al. Bismuth-based quadruple therapy versus metronidazole-intensified triple therapy as a first-line treatment for clarithromycin-resistant Helicobacter pylori infection: a multicenter randomized controlled trial. Gut Liver 2022;16:697-705.
    Pubmed KoreaMed CrossRef
  5. Jung HK, Kang SJ, Lee YC, et al. Evidence-based guidelines for the treatment of Helicobacter pylori infection in Korea 2020. Gut Liver 2021;15:168-195.
    Pubmed KoreaMed CrossRef
  6. Murata M, Sugimoto M, Mizuno H, Kanno T, Satoh K. Clarithromycin versus metronidazole in first-line Helicobacter pylori triple eradication therapy based on resistance to antimicrobial agents: meta-analysis. J Clin Med 2020;9:543.
    Pubmed KoreaMed CrossRef

Article

Editorial

Gut and Liver 2022; 16(6): 807-808

Published online November 15, 2022 https://doi.org/10.5009/gnl220414

Copyright © Gut and Liver.

Bismuth-Based Quadruple Therapy for Clarithromycin-Resistant Helicobacter pylori Infection: Effectiveness and Cost-Efficiency

Moon Won Lee , Gwang Ha Kim

Department of Internal Medicine, Pusan National University College of Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, Korea

Correspondence to:Gwang Ha Kim
ORCID https://orcid.org/0000-0001-9721-5734
E-mail doc0224@pusan.ac.kr

See “Bismuth-Based Quadruple Therapy versus Metronidazole-Intensified Triple Therapy as a First-Line Treatment for Clarithromycin-Resistant Helicobacter pylori Infection: A Multicenter Randomized Controlled Trial” by Seung In Seo, et al. on page 697, Vol. 16, No. 5, 2022

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Body

Clarithromycin-based triple therapy (CTT) is widely used for empirical first-line eradication of Helicobacter pylori. However, the efficacy of empirical CTT has gradually decreased with the increase in antibiotic resistance. Guidelines in Europe and the U.S. state that CTT is no longer recommended as the first-line therapy in areas with >15% clarithromycin resistance.1,2 A recent study showed that the resistance rate against clarithromycin was 17.8% and eradication rate of empirical CTT was 71.6% in Korea.3 Therefore, finding an optimized, cost-effective, and tailored therapy according to clarithromycin resistance is of paramount importance.

In the latest issue of Gut and Liver, Seo et al.4 compared both the efficacy and cost-effectiveness of tailored therapy as a first-line treatment using sequencing-based clarithromycin resistance testing. Eradication rates of the 14-day bismuth-based quadruple therapy (BQT) were not significantly different from that of 14-day metronidazole-intensified triple therapy (MIT) in an intention-to-treat analysis (80.4% vs 69.7%, p=0.079), but were significantly higher in the per-protocol analysis (95.1% vs 76.4%, p=0.001). Current Korean guidelines recommend 7-day proton pump inhibitor, amoxicillin, metronidazole (PAM) or 10- to 14-day BQT for clarithromycin-resistant H. pylori infection.5 However, 7-day PAM showed a significantly lower eradication rate owing to a high resistance rate against metronidazole. Metronidazole resistance is generally overcome by increasing the dose or treatment duration. In this study, eradication rate of 14-day MIT was not significantly different from that of a previous 7-day PAM study.6 In contrast, intention-to-treat and per-protocol eradication rates with 14-day BQT were 80.4% and 95.1%, respectively, reaching the recommended target rate for first-line treatment. There were no significant differences in non-compliance and prevalence of side effects between the BQT and PAM groups. Thus, 14-day BQT is an effective first-line therapy for clarithromycin-resistant H. pylori infections.

In this study,4 cost-effectiveness analyses of tailored therapy were compared with empirical CTT in first-line and second-line therapies using incremental cost-effectiveness ratio. BQT is more cost-effective than MIT. However, cost-effectiveness analysis showed an increased cost of tailored therapy compared to empirical CTT. The incremental cost-effectiveness ratio was higher in the BQT of second-line rescue therapy than in empirical CTT. This is because the sequencing-based clarithromycin resistance test (USD 57.5) used for tailored therapy is more expensive than the CLO test (USD 9.3) used for empirical therapy. When comparing regimens, cost-effectiveness is determined by efficacy of the regimen and not by its cost. Therefore, acceptance will likely be owing to socioeconomic costs, increasing antibiotic resistance, and disease prevention, whilst minimizing further utilization of healthcare resources, and eradicating H. pylori by saving on treatment costs.

In summary, 14-day BQT showed a higher eradication rate in per-protocol analysis and a comparable incidence of side effects to 14-day MIT as a first-line treatment, according to the sequencing-based clarithromycin resistance test. Moreover, it may be more cost-effective than a 14-day MIT. Tailored therapy may be increasingly used as a first-line treatment for H. pylori, and BQT should be recommended for clarithromycin-resistant H. pylori infection.

CONFLICTS OF INTEREST

G.H.K. is an editorial board member of the journal but was not involved in the peer reviewer selection, evaluation, or decision process of this article. No other potential conflicts of interest relevant to this article were reported.

References

  1. Chey WD, Leontiadis GI, Howden CW, Moss SF. ACG clinical guideline: treatment of Helicobacter pylori infection. Am J Gastroenterol 2017;112:212-239.
    Pubmed CrossRef
  2. Malfertheiner P, Megraud F, O'Morain CA, et al. Management of Helicobacter pylori infection-the Maastricht V/Florence consensus report. Gut 2017;66:6-30.
    Pubmed CrossRef
  3. Lee JH, Ahn JY, Choi KD, et al. Nationwide antibiotic resistance mapping of Helicobacter pylori in Korea: a prospective multicenter study. Helicobacter 2019;24:e12592.
    Pubmed CrossRef
  4. Seo SI, Lim H, Bang CS, et al. Bismuth-based quadruple therapy versus metronidazole-intensified triple therapy as a first-line treatment for clarithromycin-resistant Helicobacter pylori infection: a multicenter randomized controlled trial. Gut Liver 2022;16:697-705.
    Pubmed KoreaMed CrossRef
  5. Jung HK, Kang SJ, Lee YC, et al. Evidence-based guidelines for the treatment of Helicobacter pylori infection in Korea 2020. Gut Liver 2021;15:168-195.
    Pubmed KoreaMed CrossRef
  6. Murata M, Sugimoto M, Mizuno H, Kanno T, Satoh K. Clarithromycin versus metronidazole in first-line Helicobacter pylori triple eradication therapy based on resistance to antimicrobial agents: meta-analysis. J Clin Med 2020;9:543.
    Pubmed KoreaMed CrossRef
Gut and Liver

Vol.16 No.6
November, 2022

pISSN 1976-2283
eISSN 2005-1212

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